(175 days)
Not Found
No
The device description and intended use clearly describe a liquid used for coloring dental zirconia, with no mention of any computational or algorithmic processes, let alone AI/ML. The "Mentions AI, DNN, or ML" section also explicitly states "Not Found".
No
The device is a coloring liquid used for aesthetic purposes (matching tooth color), not for treating or diagnosing a medical condition or disease.
No
Explanation: The device is a coloring liquid used to match dental restorations to the patient's natural tooth color. It does not identify or detect a disease, condition, or state of health.
No
The device is a liquid used for coloring dental zirconia, which is a physical substance and not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "complete or partial coloration of milled zirconia substructure and anatomy before sintering." This is a process performed on a dental restoration outside of the body.
- Device Description: The description details a liquid used for staining dental zirconia frameworks and restorations prior to sintering. This is a laboratory or dental office procedure, not a diagnostic test performed on a biological sample.
- Lack of Biological Sample Analysis: IVDs are designed to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not interact with or analyze any biological samples.
The device is a material used in the fabrication of dental restorations, not a diagnostic tool.
N/A
Intended Use / Indications for Use
Coloring Liquid is a liquid used for the complete or partial coloration of milled zirconia substructure and anatomy before sintering.
Product codes (comma separated list FDA assigned to the subject device)
EIH
Device Description
Coloring Liquid is water based, which consist of watery, acidic metal salt solutions. They are used for the individual staining of dental zirconia frameworks and restorations prior to the final sintering of the restoration, enabling the user to adjust the restoration to match the natural color of the patient's teeth. Coloring Liquid is provided in 45 different shades, which are corresponding to patient's closest tooth color. For staining, the zirconia materials have to be immerged into the liquids or to be brushed with the liquids, prior to sintering at high temperatures
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Bench testing was performed to ensure that the Coloring Liquid met its specifications. All tests were verified to meet acceptance criteria. Biocompatibility testing was performed to verify the equivalent safety of the materials that are used.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 872.6660 Porcelain powder for clinical use.
(a)
Identification. Porcelain powder for clinical use is a device consisting of a mixture of kaolin, felspar, quartz, or other substances intended for use in the production of artificial teeth in fixed or removable dentures, of jacket crowns, facings, and veneers. The device is used in prosthetic dentistry by heating the powder mixture to a high temperature in an oven to produce a hard prosthesis with a glass-like finish.(b)
Classification. Class II.
0
Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue.
June 29, 2022
Dongguan Xiangtong Co., Ltd. Charles Shen Director Manton Business and Technology Services 37 Winding Ridge Oakland, New Jersey 07436
Re: K220017
Trade/Device Name: Coloring Liquid Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain Powder For Clinical Use Regulatory Class: Class II Product Code: EIH Dated: May 28, 2022 Received: June 3, 2022
Dear Charles Shen:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
1
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Michael E. Adjodha, M.ChE. Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
Device Name Coloring Liguid
Indications for Use (Describe)
Coloring Liquid is a liquid used for the complete or partial coloration of milled zirconia substructure and anatomy before sintering.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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K220017 Section 5: 510(k) Summary:
This summary of 510k safety and effectiveness information is being submitted In accordance with the requirements of 21CFR 807.92
Submitter & Foreign Manufacture Identification 5.1
DONGGUAN XIANGTONG CO., LTD NO.4. Tech 9th Rd, Hi-Tech Industrial Development Zone, Songshan Lake, Dongguan, Guangdong, China., Zipcode 523000 Tel: (086)-0769-22895688 Submitter's FDA Registration Number: N/A
Contact Person 5.2
Image /page/3/Picture/6 description: The image shows a logo for a company that appears to be in the medical field. The logo features a stylized letter 'M' in blue, with a crescent shape above it in light blue. The company name, "曼度医械", is written in orange above the 'M'. The overall design is simple and modern, with a focus on the company's initials.
Charles Shen Manton Business and Technology Services 37 Winding Ridge, Oakland, NJ 07436 Tel: 608-217-9358 Email: cyshen@aol.com
5.3 Date of Summary: December 19, 2021
| 5.4 | Device Name: |
|---|---|
| ----- | -------------- |
| Proprietary Name: | Coloring Liquid |
|---|---|
| Common Name: | Coloring Liquid |
| Classification Name: | Powder, Porcelain |
| Device Classification: | II |
| Regulation Number: | 21 CFR 872.6660 |
| Panel: | Dental |
| Product Code: | EIH |
5.5 Predicate Device Information:
- K141723, "Upcera Coloring Liquid (I and II)", manufactured by "Liaoning (1) Upcera Co., Ltd." located in Benxi, China
5.6 Device Description:
Coloring Liquid is water based, which consist of watery, acidic metal salt solutions. They are used for the individual staining of dental zirconia frameworks and restorations prior to the final sintering of the restoration, enabling the user to adjust the restoration to match the natural color of the patient's teeth.
4
Coloring Liquid is provided in 45 different shades, which are corresponding to patient's closest tooth color. For staining, the zirconia materials have to be immerged into the liquids or to be brushed with the liquids, prior to sintering at high temperatures
5.7 Indications for Use:
Coloring Liquid is a liquid used for the complete or partial coloration of milled zirconia substructure and anatomy before sintering.
న్ని శిశు సంరక్షణ కేంద్రం, మూలాలు గ్రామం నుండి 10 కి.మీ. దూరంలో ఉంది. ప్రాథమిక ఆరోగ్యామ్ నిర్మాణ ప్రాథమిక ఆరోగ్యామ్ కూడా ఉంది. మాతా శిశు సంరక్షణ కేంద్రం, మూలాలు విశాఖపట్న Summary of Device Testing:
Bench testing was performed to ensure that the Coloring Liquid met its specifications. All tests were verified to meet acceptance criteria. Biocompatibility testing was performed to verify the equivalent safety of the materials that are used.
5.9 Comparison With Predicate Device
Coloring Liquid is compared with the following Predicate Devices in terms of intended use, design, material, specifications, and performance.
- (1) K141723, "Upcera Coloring Liquid (I and II)", manufactured by "Liaoning Upcera Co., Ltd." located in Benxi, China
The following table shows similarities and differences of use, design, and material between our device and the predicate devices.
| Description | Subject Device | Predicate Device (K141723) |
|---|---|---|
| Indication for | ||
| Use | Coloring Liquid is a liquid used for the | |
| complete or partial coloration of milled | ||
| zirconia substructure and anatomy before | ||
| sintering. | Upcera Coloring Liquid (I and II) is a | |
| liquid used for the complete or partial | ||
| coloration of milled Upcera zirconia | ||
| substructure and anatomy before | ||
| sintering. | ||
| Technology | Water based with inorganic pigments | Water based with inorganic pigments |
| Operating | ||
| Principle | Brush or immerse zirconia ceramic materials | |
| with coloring liquid before sintering | Brush or immerse zirconia ceramic | |
| materials with coloring liquid before | ||
| sintering | ||
| Ingredient | Water, Polyethylene glycol, inorganic salts | Water, Polyethylene glycol, inorganic |
| salts | ||
| Bottle Size | Various | Various |
| Shade | Various | Various |
| Prescription | Yes | Yes |
Table 5.1: Comparison of Intended Use, Design, Material, and Processing
5
| Sterile | Non-sterile | Non-sterile |
|---|---|---|
| --------- | ------------- | ------------- |
The subject device is similar to the predicate device in terms of indications for use, technology, and principle of operation.
The following table shows similarities and differences of the safety tesing between our device and the predicate devices.
Table 5.2: Comparison of Safety Testing
| Description | Subject Device | Predicate Device (K141723) |
|---|---|---|
| Cytotoxicity | ||
| (ISO 10993-5:2009) | No cytotoxicity effect | No cytotoxicity effect |
| Irritation Oral Mucosa | ||
| Irritation | ||
| (ISO 10993-10: 2010) | Not a primary oral mucosa | |
| irritant under the conditions of | ||
| the study | Not a primary oral mucosa | |
| irritant under the conditions of | ||
| the study | ||
| Sensitization (ISO | ||
| 10993-10: 2010) | Not a sensitizer under the | |
| conditions of the study | Not a sensitizer under the | |
| conditions of the study | ||
| Acute Systemic Toxicity | ||
| and Subchronic Toxicity | ||
| (ISO 10993-11: 2006) | No Acute Systemic Toxicity and | |
| subchronic toxic effects | ||
| observed | No acute and subchronic toxic | |
| effects observed | ||
| Genotoxicity (ISO | ||
| 10993-3:2003) | No genotoxic effects observed | No genotoxic effects observed |
5.10 Non-clinical Testing
Non-clinical Testing Bench testing was performed to ensure the Coloring Liquid met its specifications. All tests were verified to meet acceptance criteria. Biocompatibility testing was performed to verify the substantially equivalent safety of the materials that are used.
5.11 Conclusions
It has been shown in this 510(k) submission that "Coloring Liquid" and its predicate devices have the identical indications for use, similar composition and biocompatibility, similar manufacturing process, and similar performance.
The difference between the "Coloring Liquid" and their predicate device do not raise any question regarding its equivalence.
"Coloring Liquid", as designed and manufactured, is substantially equivalent as its predicate device.